Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:31 AM
Ignite Modification Date: 2025-12-25 @ 11:44 PM
NCT ID: NCT02522494
Description: None
Frequency Threshold: 0
Time Frame: From the baseline (Pre-CVT visit interview Visit 1) to the follow-up telephone interview (four weeks past Post-CVT visit), an average of 3 months per participant. Time frame varies depending on occurrence of patients' Clinical Video Telehealth visits with their physicians in routine clinical practice.
Study: NCT02522494
Study Brief: Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Patients randomized to the intervention arm worked with educational materials: 1) they view the intervention video that encouraged patients to use active communication behaviors showing positive role models overcoming common communication challenges in CVT visit, and 2) they read the pamphlet that described how to use active communication behaviors in CVT visits Both educational materials (the video and pamphlet) had been mailed to the participants. The participants worked with the educational materials prior to their scheduled CVT visit. 0 None 0 37 0 37 View
Pamphlet Alone Patients randomized to the control arm only read the pamphlet. The same pamphlet as in the intervention group had been mailed to the control patients prior to their scheduled CVT visit. 1 None 1 48 0 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):